Sections the letter addresses (its own headings, read from the PDF's text layer; labeling and administrative sections omitted): Product Quality; Nonclinical; Facility Inspections.
Daily close, T-120 (11/6/25) through T+5. Run-up high $5.13 on 4/3/26, low $2.99 on 11/17/25 (T-120 to T-1). FDA decision 4/23/26. Historical price action, not a forecast.
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was GTX-104 approved by the FDA?
Not in this review cycle. A Complete Response Letter, declining to approve the application for GTX-104 in its current form, was announced on April 23, 2026. A CRL is not final; the primary source is linked on this page.
Which company is behind GTX-104?
GTX-104 is a Grace Therapeutics Inc. (GRCE) program. The company announced the FDA decision on April 23, 2026; the FDA's own record of the decision is linked on this page.
How did GRCE stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), GRCE moved +37.7%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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